Cardiovascular events, including arterial vascular occlusive events, peripheral arterial occlusive events and ischemic cerebrovascular events have been reported in patients receiving tyrosine kinase inhibitors. If acute signs or symptoms of cardiovascular events occur, patients should seek immediate medical attention. The cardiovascular status and risk factors of patients should be evaluated prior to therapy and cardiovascular monitoring and management should take place during treatment.

Fluid retention occurs with BCR-ABL tyrosine kinase inhibitors therapy and may manifest as pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Caution should be taken when using these drugs in patients with preexisting fluid retention or congestive heart failure. Monitor and manage patients using standards of care. Interrupt, reduce dose or discontinue therapy as necessary.

Moderate

BCR-ABL tyrosine kinase inhibitors- bone marrow suppression

Thrombocytopenia, aplastic anemia, agranulocytosis and neutropenia occur with BCR-ABL tyrosine kinase inhibitors. Therapy with these drugs should be administered cautiously in patients with preexisting bone marrow suppression. A complete blood count should be performed every 1-2 weeks for the first month of therapy and then monthly thereafter, or as clinically indicated. To manage myelosuppression, withhold, reduce dose, or discontinue therapy as necessary.

Moderate

Imatinib (Includes Gleevec) ↔ gastrointestinal disorders

Imatinib has been sometimes associated with GI irritation, and it should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including fatalities, of gastrointestinal perforation. Caution should be used in patients with history of GI disorders.

Moderate

Imatinib (Includes Gleevec) ↔ hepatic impairment

Patients with severe hepatic impairment tend to have higher exposure to both imatinib and its metabolite than patients with normal hepatic function, and dose might need to be adjusted accordingly. Additionally, there have been reports of hepatotoxicity both with short and long term use of imatinib. Liver function should be monitored before initiation of treatment and regularly during therapy. Dose reduction or interruption might be needed if laboratory abnormalities are found.

Moderate

Imatinib (Includes Gleevec) ↔ hypothyroidism

Hypothyroidism cases have been reported in thyroidectomy patients undergoing levothyroxine replacement therapy during treatment with imatinib. Caution should be used in these patients and TSH levels should be monitored closely.

Moderate

Imatinib (Includes Gleevec) ↔ renal impairment

The mean exposure to imatinib is increased in patients with renal impairment compared to those with normal renal function. Dose reductions are necessary in patients with moderate and severe renal impairment.